Beyond the Lung Cancer Diagnosis: Leveraging the Oncology Clinic Setting for Actively Smoking Family Members

NCT03966807 | Terminated DMC

• 1 other identifier: IUSCC-0670
• Study Type: observational
• Target: 4
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this pilot study is to examine, in an innovative setting, the potential for a lung cancer diagnosis in a loved one to represent a teachable moment for smoking cessation in family members or caregivers who are current smokers. The researchers will identify the willingness and preferred modality for smoking cessation among family members/caregivers in this setting. The researchers will estimate abstinence rates at 4, 8, 12, and 24 weeks..

Conditions

Lung Cancer

Keywords

lung cancer; caregiver

Outcome Measures

Primary Outcomes (12)

• 7-day point prevalence of self -reported smoking cessation

  4 weeks

• 7-day point prevalence of self -reported smoking cessation

  8 weeks

• 7-day point prevalence of self -reported smoking cessation

  12 weeks

• 7-day point prevalence of self -reported smoking cessation

  24 weeks

• Willingness to quit

  4 weeks

• Willingness to quit

  8 weeks

• Willingness to quit

  12 weeks

• Willingness to quit

  24 weeks

• Preference for type of cessation intervention modality

  digital versus traditional support with nicotine replacement therapy \[NRT\]

  4 weeks

• Preference for type of cessation intervention modality

  digital versus traditional support with nicotine replacement therapy \[NRT\]

  8 weeks

• Preference for type of cessation intervention modality

  digital versus traditional support with nicotine replacement therapy \[NRT\]

  12 weeks

• Preference for type of cessation intervention modality

  digital versus traditional support with nicotine replacement therapy \[NRT\]

  24 weeks

Secondary Outcomes (15)

• Mean change in readiness to quit

  Baseline

• Mean change in readiness to quit

  4 weeks

• Mean change in readiness to quit

  8 weeks

• Mean change in readiness to quit

  12 weeks

• Mean change in readiness to quit

  24 weeks

Study Arms (2)

Digital-based support

Digital support will consist of referral for the participant to visit https://smokefree.gov, a website which offers a menu of internet- and text-based support options.

Behavioral: Digital-based support

traditional-based support +nicotine replacement therapy(NRT)

Traditional support will consist of participant referral to the Indiana Tobacco Quitline (1-800-QUIT-NOW) which is a telephone hotline that connects participants to Indiana smoking cessation resources.

Behavioral: Traditional-based support + Nicotine replacement therapy (NRT)

Interventions

Digital-based support BEHAVIORAL

Digital support will consist of referral for the participant to visit https://smokefree.gov, a website which offers a menu of internet- and text-based support options.

Digital-based support

Traditional-based support + Nicotine replacement therapy (NRT) BEHAVIORAL

Traditional support will consist of participant referral to the Indiana Tobacco Quitline (1-800-QUIT-NOW) which is a telephone hotline that connects participants to Indiana smoking cessation resources.

traditional-based support +nicotine replacement therapy(NRT)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with newly diagnosed lung cancers will be identified from the daily patient lists at the thoracic oncology clinics at IUSCC, Roudebush VAMC, and Eskenazi. The study coordinator will screen for newly diagnosed lung cancer patients to identify potential family member/caregiver study participants. Patients will be approached and asked whether they have any family members/caregivers who smoke, and if they would be willing to allow the study team to contact those people (or person) with information about the study. For patients who agree and have family members/caregivers present at the clinic visit that day, the study coordinator (or other designated member of the study team) will discuss the purpose of the study and utilize the 5A strategy (Ask, Advice, Assess willingness to quit, Assist, Arrange follow-up) to ascertain interest in participation.

You may qualify if:

• patient with newly diagnosed lung cancer within the last 6 months of initial diagnosis/confirmation of diagnosis at the study sites
• Able to provide informed consent
• Able to speak and read English
• Family Member/Caregiver Participant Criteria:
• Family member or caregiver (defined as first degree relative \[parent, sibling, child\] or person living in the same household)
• Family member or caregiver must be a current, active smoker (defined as 10 cigarettes per day for 6 consecutive months).
• At least 18 years of age at time of study consent
• Able to provide informed consent
• Able to speak and read English

You may not qualify if:

• Currently receiving formal tobacco dependence treatment- Nicotine replacement of any kind, varenicycline or Bupropion.
• Medical condition that precludes proposed pharmacotherapy for smoking cessation : Recent (≤ 2 weeks) myocardial infarction , history of underlying arrhythmias , history of serious or worsening angina pectoris, pregnancy and breastfeeding

Sponsors & Collaborators

• Indiana University: lead

Study Sites (1)

Indiana University Melvin & Bren Simon Cancer Center

Indianapolis, Indiana, 46202, United States

Location

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Nicotine Replacement Therapy

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Drug Therapy; Therapeutics

Study Officials

• Shadia Jalal, MD

  Indiana University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Clinical Medicine

Study Record Dates

• First Submitted: March 18, 2019
• First Posted: May 29, 2019
• Study Start: September 13, 2021
• Primary Completion: March 29, 2022
• Study Completion: March 29, 2022
• Last Updated: January 18, 2024

Record last verified: 2024-01

Locations

US (1)